By John R. Fleder, Douglas B. Farquhar & Peter M. Jaensch – The U.S. Department of Justice announced on November 9, 2010, the government version of a six-count indictment filed in the District of Maryland against Lauren Stevens, a former Vice President and Associate General Counsel for a brand …
By Peter M. Jaensch & John R. Fleder – A company has “current Good Manufacturing Practice” (“cGMP”) issues. FDA learns about the issues and engages in dialogue with the company regarding the purported violations. No big deal and no news story! Add in a terminated employee who files …
By John R. Fleder – It is hardly a secret that FDA’s favorite regulated industry is certainly not the businesses that compound pharmaceutical products. For years FDA has struggled to establish an enforcement mechanism that passes muster with Congress and the courts. Two compounding pharmacies have …
By John R. Fleder – We earlier reported that the United States Sentencing Commission issued an interesting Federal Register notice on January 21, 2010. We reported that the Commission has proposed to amend the Sentencing Guidelines to require companies to make restitution to identifiable victims, and …
By Peter M. Jaensch & John R. Fleder – The January 21, 2010 Federal Register contains a notice that the United States Sentencing Commission has proposed amendments to the Sentencing Guidelines and their Commentary concerning corporations and other business organizations. In addition, the Commission has raised an issue …
By William T. Koustas & John R. Fleder – A new lawsuit challenges the government’s ability to exclude individuals from participating in federal health care programs after a person has been convicted of a Food, Drug and Cosmetic Act (“FDCA”) misdemeanor. Michael Friedman and Howard R. Udell …
By John R. Fleder – On December 4, 2009, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued a 24-page Opinion in James Hopper v. Solvay Pharmaceuticals, Inc., No. 08-15810. The Court affirmed the District Court’s dismissal of a False Claims Act …
By John R. Fleder – Numerous states have filed lawsuits across the country alleging that pharmaceutical companies have defrauded the Medicaid system by “publishing” inflated prices, namely “AWP” and “WAC” prices, that do not accurately reflect the prices at which those companies actually sell their products. …
By William T. Koustas & John R. Fleder – FDA-regulated businesses are certainly closely regulated by FDA and other federal agencies. However, one area that many of these businesses erroneously believe does not affect them is the federal laws and regulations that apply to identity theft. The …
By William T. Koustas, Dara Katcher Levy, and John R. Fleder – On April 28, 2009, Smoking Everywhere, Inc. (“SE”) sued FDA to “stop FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes” to the extent that FDA declared such products to …
By John R. Fleder – On May 5, 2009, the White House announced that President Obama intends to nominate former South Carolina State Superintendent of Education Inez Moore Tenenbaum as Chair of the United States Consumer Product Safety Commission (“CPSC”) and also University of North Carolina …
By Ricardo Carvajal & John R. Fleder – In Federal Trade Commission v. Medlab, Inc., the United States District Court for the Northern District of California granted summary judgment on April 21, 2009, to the FTC in an action against a marketer of weight loss products, which …
By JP Ellison & John R. Fleder – The Supreme Court’s April 22, 2009 decision in NKEN v. HOLDER relates to expediting the removal of aliens from this country. The decision merits mention here because it preserves the ability of appellate courts to stay government action pending …
By Ricardo Carvajal & John R. Fleder – On April 20, 2009, the U.S. Supreme Court let stand the Third Circuit’s decision in Fellner v. Tri-Union Seafoods. As we discussed in a prior posting, Fellner’s lawsuit contends that Tri-Union is guilty of negligence under New Jersey …
By Ricardo Carvajal & John R. Fleder – On April 17, 2009, DOJ’s Office of Information Policy (“OIP”) issued guidance to federal agencies on President Obama’s FOIA Memorandum of January 21st and Attorney General (“AG”) Holder’s subsequent FOIA March 19th guidelines. The President’s FOIA memorandum directed …
